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      CMD中國醫療器械質量認證

       北京國醫械華光認證有限公司(原中國醫療器械質量認證中心)是由國家認證認可監督管理委員會批準(批準號:CNCA-R-2002-047),并實施工商登記注冊,具有獨立法人地位的第三方認證機構。是具有產品認證和質量管理體系認證的國家雙重認可資格的法律實體。

      Authentication service                                    Training service                                         Technical service                                   Strategic cooperation                                    Data download

      培訓服務

      TRAINING SERVICE

      • 培訓課程
      • 培訓講師
      • 培訓計劃
      • 會員制度
      • 網絡課程
      • 學員反饋

      培訓課程介紹

      一、 醫療器械內審員培訓班,主要內容:

      1.   GB/T19000族標準簡介及基礎術語

      2.   2015ISO 90012003ISO13485標準講解

      3.   質量管理體系建立健全及文件的編寫

      4.   內審方法與技巧

       

      二、   醫療器械風險管理(YY/T0316ISO14971)標準解讀)培訓班,主要內容:

      1.   風險管理的重要性

      2.   中國法規有關醫療器械風險管理的要求

      3.   風險管理標準在中國的實施情況

      4.   質量管理體系中對風險管理的要求

      5.   風險管理流程在質量管理中的應用

      6.   需要注意的問題


      三、 醫療器械風險管理高級應用培訓班,主要內容:  

      1.   YY/T0316ISO14971)標準解讀

      2.   ISO24971“風險管理指南”標準解讀

      3.   中國法規關于風險管理的要求

      4.   質量管理體系中應建立的風險管理要求

      5.   醫療器械風險管理的流程

      6.   風險管理流程在產品實現過程中的應用

      a)   產品設計開發過程中的風險管理

      b)   采購過程中的風險管理

      c)   生產過程中的風險管理

      d)   產品上市后的質量反饋、糾正預防措施和風險管理

      e)   風險管理文檔的建立和維護

      7.   產品標準例如GB9706GB16886在風險管理中的應用


      技術服務

      TECHNICAL SERVICE

      • 公司簡介
      • 產品介紹
      • 技術服務特色

             北京國醫械華光認證有限公司((原中國醫療器械質量認證中心)是由國家認證認可監督管理委員會批準(批準號:CNCA-R-2002-047),并實施工商登記注冊,具有獨立法人地位的第三方認證機構。是具有產品認證和質量管理體系認證的國家雙重認可資格的法律實體。


      CMD認真執行國家有關法律法規,按照國家認證機構認可準則的要求規范運行、依法認證。CMD繼承了原中國醫療器械質量認證中心的全部資質,具有一支經驗豐富的國家注冊高級審核員、審核員和專家隊伍,在多年的產品認證和質量管理體系認證工作中積累了豐富的認證經驗。


      CMD不斷樹立在醫療器械行業認證的權威性,贏得了醫療器械監督管理部門、各類醫療器械生產企業和廣大醫療器械用戶的信任,并且在全國范圍建立了醫療器械認證網絡。CMD持續跟蹤國際醫療器械認證發展動態,與世界醫療器械認證水平保持同步,并且和世界各國醫療器械認證機構有著廣泛的交流與合作。


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